Drug OTC Product Licensing

We can handle your DIN- labelling standard and Category IV Monograph DIN applications. These are determined by the amount and ingredients in your product. When the dose is higher than an NHPD Monograph- the product may fall into this category which requires a modified DIN application for product license approval. The application still follows the eCTD format. Though it is modified and shortened to accommodate for the lower-risk ingredients in the following product categories.

The Category IV Monographs include:

  • Acne Therapy
  • Sunscreen Monograph
  • Medicated Skin Care Products
  • Diaper Rash Products
  • Anti-Dandruff Products
  • Antiseptic Skin Cleansers
  • Athletes Foot Treatments
  • Throat lozenges
  • Disinfectants